Is Finerenone (Finerenone) 5 mg safe for patients with End-Stage Renal Disease (ESRD)?

Finerenone 5 mg is NOT Appropriate for ESRD

Finerenone should not be used in patients with end-stage renal disease (ESRD), as the landmark trials specifically excluded patients with eGFR <25 mL/min/1.73 m², and there is no established dosing or safety data for this population. 1

Evidence Base and Trial Populations

The major finerenone trials (FIDELIO-DKD and FIGARO-DKD) that established its efficacy and safety profile had strict eGFR inclusion criteria:

• FIDELIO-DKD: Enrolled patients with eGFR ≥25 to <75 mL/min/1.73 m² 1, 2
• FIGARO-DKD: Enrolled patients with eGFR 25-90 mL/min/1.73 m² 1
• FIDELITY pooled analysis: Combined data from both trials, maintaining the eGFR ≥25 mL/min/1.73 m² threshold 1, 3

These trials demonstrated significant cardiovascular and renal benefits, including a 36% reduction in progression to ESKD 1, but this evidence applies only to patients with CKD stages 2-4, not those already in ESRD.

Dosing Considerations That Exclude ESRD

The approved dosing algorithm further clarifies that finerenone is not intended for ESRD:

• eGFR 25-60 mL/min/1.73 m²: Start 10 mg once daily 1, 4
• eGFR >60 mL/min/1.73 m²: Start 20 mg once daily 1, 4
• eGFR <25 mL/min/1.73 m²: No dosing recommendations exist 1, 2

The 5 mg dose mentioned in your question is not a standard starting dose in any guideline or trial protocol. The lowest approved starting dose is 10 mg daily for patients with eGFR 25-60 mL/min/1.73 m² 1, 4.

Hyperkalemia Risk in Advanced CKD

Hyperkalemia is the primary safety concern with finerenone, and this risk escalates dramatically in patients with severely reduced kidney function:

• In trial populations (eGFR ≥25 mL/min/1.73 m²), hyperkalemia occurred in 10.8% vs 5.3% with placebo 1
• Treatment discontinuation due to hyperkalemia was 2.3% in FIDELIO-DKD (patients with more advanced CKD) vs 1.2% in FIGARO-DKD 1, 4
• Patients with eGFR <60 mL/min/1.73 m² had higher discontinuation rates (2.4%) compared to those with eGFR ≥60 (0.6%) 3

In ESRD patients, the risk of life-threatening hyperkalemia would be substantially higher and unpredictable, as these patients were systematically excluded from all safety analyses. 2, 3

Appropriate Referral Threshold

The American Diabetes Association guidelines explicitly recommend nephrology referral when eGFR falls below 30 mL/min/1.73 m² (stage 4 CKD) for discussion of renal replacement therapy 1. This threshold is well above ESRD and represents the point where finerenone evidence becomes limited.

Clinical Algorithm for Finerenone Use

Do NOT initiate finerenone if:

• eGFR <25 mL/min/1.73 m² 1, 2
• Patient is on dialysis or has ESRD 2, 3
• Baseline potassium >4.8 mmol/L 1, 4
• Heart failure with reduced ejection fraction 1

Consider finerenone if:

• eGFR 25-90 mL/min/1.73 m² 1, 3
• Type 2 diabetes with albuminuria (UACR ≥30 mg/g) 1, 4
• Already on maximum tolerated ACE inhibitor or ARB 4, 5
• Potassium ≤4.8 mmol/L 1, 4

Bottom Line

For patients with ESRD, finerenone is contraindicated by the absence of any supporting evidence, lack of dosing guidance, and prohibitive hyperkalemia risk. 2, 3 The medication's proven benefits in reducing progression to ESKD are irrelevant once a patient has already reached end-stage disease. If a patient with CKD stage 4 (eGFR 15-29 mL/min/1.73 m²) is being considered, nephrology consultation is mandatory before any consideration of finerenone, though even in this population, evidence is extremely limited. 1